MARCH 11, 2014 By: Susan Green
The opening witness in the first“bellwether” Actos cancer trial told the jury about drug manufacturer Takeda’s pretrial misconduct.
The case is the first of several scheduled in the ongoing Actos Multidistrict
Litigation (MDL) in federal court in Louisiana.
Terrence Allen and his wife’s lawsuit charges that Allen developed
bladder cancer as a result of using Actos to treat diabetes between 2004
and 2011. Plaintiffs argue that Actos manufacturer Takedafailed to disclose the link between Actos and bladder cancer. Takeda claims that Allen’s cancer was not caused by the drug, and
that the company provided proper notification of Actos’s risks.
Takeda’s pretrial misconduct
Just before the Allens’ Actos cancer trial began on January 27, the
judge ruled that
Takeda had acted in bad faith by
hiding or destroying evidence that the company should have given plaintiffs during the pretrial process.
The judge held that plaintiffs could reveal Takeda’s improper actions
to the jury. Thus plaintiffs’ first witness was an Actos employee,
who testified about the company’s evidentiary misconduct.
The next witness was Dr. David Kessler, a physician who served as Commissioner
of the FDA from 1990-1997. Dr. Kessler told the jury that the FDA is required
to determine that a drug is safe and effective before the agency can authorize
that drug’s use in the United States. Dr. Kessler described the
types of data Takeda was required to obtain to demonstrate Actos’s
safety and effectiveness, and explained what the manufacturer was obligated
to show the FDA in order to obtain authorization for the drug.
Several medical experts then testified about the
studies linking Actos use to a high risk of bladder cancer. Takeda employees also took the witness stand to describe what the company
knew about the connection between bladder cancer and Actos use.
Actos cancer trial details
Millions of Americans have used Actos to treat their Type 2 diabetes since
the FDA approved the drug in 1999. In 2011, however, the FDA advised that
use of Actos for longer than one year increased patients’ risk of
bladder cancer by as much as 40% compared to patients who had never used the drug. The FDA’s advice was based on results after five years of a planned
ten-year study of over 193,000 diabetes patients.
Nearly 3,000 Actos cancer lawsuits were centralized in the Louisiana federal
court as a way to streamline pretrial proceedings. The MDL procedure allows
the court to resolve pretrial issues common to all the lawsuits at one
time. Then the parties select a few representative or “bellwether”
cases to go to trial. The procedure often facilitates settlement, as defendants
understand the likely outcome of the remaining cases, and try to minimize
the time and expense of multiple separate trials.
On top of the thousands of cases pending in the MDL, many other patients
have filed lawsuits in state courts around the country charging that Actos
caused bladder cancer. To date at least three cases have been concluded.
Two 2013 trials resulted in jury verdicts of $1.7 million and $6.5 million,
although the verdicts ultimately were vacated. A third trial led to a
decision in favor of Takeda.
The Actos cancer trial in Louisiana will continue to draw attention as
witnesses testify for both sides. Based on the parties’ original
jury should begin its deliberations sometime in late March.
If you have suffered injuries from a pharmaceutical drug, contact our
Wichita personal injury attorneys today for a free consultation.